A Study To Evaluate The Safety And Effectiveness Of MOR202 In Anti-PLA2R Antibody-positive Membranous Nephropathy

Overview

About this study

The purpose of this study is to assess the safety and tolerability of MOR202 treatment in subjects with Antibody Positive Membranous Nephropathy (aMN).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 to ≤ 80 years (at date of signing ICF).
  • Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g (as measured from a 24 hour urine collection).
  • Active and anti-PLA2R antibody positive MN in need for IST according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
  • Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73m² or >30 and < 50 ml/min/1.73m², and IFTA (interstitial fibrosis and tubular atrophy) score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening. If a subject falls into the latter range without availability of an adequate biopsy, a biopsy at screening should be performed for IFTA assessment.
  • The subject is on supportive treatment with an ACEI or an ARB for at least 4 weeks prior to screening. The ACEI or ARB treatment should have reached a stable dose according to best local practice.
  • Systolic BP ≤ 150 mmHg and diastolic BP ≤ 100 mmHg after a period of 5 minutes of rest as measured at screening.
  • Subject vaccinated against Pneumococcus within the last 3 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days (1)).
  • Cohort 1a (newly diagnosed patients):
    • Serum anti-PLA2R antibodies ≥ 150.0 RU/mL determined at screening by Euroimmun ELISA.
  • Cohort 1b (relapse subjects):
    • Must have had complete immunological and/or clinical remission lasting for at least 6 months according to clinical judgement and serum anti-PLA2R antibodies ≥ 50.0 RU/mL determined at screening by Euroimmun ELISA.
  • Cohort 2:
    • Failure of immediate previous therapy; i.e. subject never achieved a complete immunological and/or clinical remission according to clinical judgement during or after completion of a recognized IST containing CSA, tacrolimus, MMF, ACTH or alkylating agents (e.g., cyclophosphamide), or RTX determined after at least 6 months after start of this IST. Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening by the Euroimmun ELISA. 11.
  • Cohort 2:
    • Subjects may have received a maximum of two prior treatment lines of immunosuppressive therapy (retreatment for relapse with the same regimen is considered a line of its own). A planned, fixed sequence of different therapeutic agents (e.g., STARMEN(2) regimen) is considered as one regimen.
  • Note: France will only enroll patients in Cohort 2. Parameters in italics are measured in a central laboratory.

Exclusion Criteria:

  • Hemoglobin < 90 g/L;
  • Thrombocytopenia:
    • Platelets < 100.0 x 10^9 /L;
  • Neutropenia:
    • Neutrophils < 1.5 x 10^9 /L.
  • Leukopenia:
    • Leukocytes <3.0 x 10^9 /L.
  • Hypogammaglobulinemia:
    • Serum immunoglobulins ≤ 5.0 g/L.
  • Secondary cause of MN (e.g., SLE, medications, malignancies) as determined by the investigator.
  • Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Nabeel Aslam, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available